U.S. patent number 10,226,542 [Application Number 15/322,834] was granted by the patent office on 2019-03-12 for device for the sterilization of stethoscopes.
This patent grant is currently assigned to Egohealth S.r.l.. The grantee listed for this patent is Egohealth S.r.I.. Invention is credited to Sandra Burgassi, Gabriele Cevenini, Daniele Messina, Gabriele Messina, Valerio Montagnani.
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United States Patent |
10,226,542 |
Messina , et al. |
March 12, 2019 |
Device for the sterilization of stethoscopes
Abstract
This invention relates to a device for sanitising of medical
instruments, in particular stethoscopes. In particular, this
invention relates to a sanitisation or sterilisation device (1) for
a stethoscope (S) comprising a case (2) that accommodates
sanitisation or sterilisation means (3, 3', 3''), a command and
control unit (4) and a battery (5), said device (1) comprising
means for coupling to the stethoscope (S) to be sanitised or
sterilised, said coupling means being magnetic or electromagnetic
coupling means (12), mechanical coupling means (13) or a
combination of them, characterised in that said case (2) presents
to the outside a recess which forms an inverted cone (11), the base
of which is open and substantially at the level of the outer
surface of the case (2), said sanitisation or sterilisation means
(3, 3', 3'') being arranged in correspondence to said cone
(11).
Inventors: |
Messina; Gabriele (Siena,
IT), Burgassi; Sandra (Siena, IT),
Montagnani; Valerio (Siena, IT), Messina; Daniele
(Siena, IT), Cevenini; Gabriele (Siena,
IT) |
Applicant: |
Name |
City |
State |
Country |
Type |
Egohealth S.r.I. |
Siena |
N/A |
IT |
|
|
Assignee: |
Egohealth S.r.l. (Siena,
IT)
|
Family
ID: |
51494381 |
Appl.
No.: |
15/322,834 |
Filed: |
May 29, 2015 |
PCT
Filed: |
May 29, 2015 |
PCT No.: |
PCT/IB2015/054075 |
371(c)(1),(2),(4) Date: |
December 29, 2016 |
PCT
Pub. No.: |
WO2016/001776 |
PCT
Pub. Date: |
January 07, 2016 |
Prior Publication Data
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|
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Document
Identifier |
Publication Date |
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US 20180200396 A1 |
Jul 19, 2018 |
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Foreign Application Priority Data
|
|
|
|
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Jul 4, 2014 [IT] |
|
|
MI2014A1221 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61L
2/10 (20130101); A61L 2/24 (20130101); A61L
2202/122 (20130101); A61L 2202/14 (20130101); A61L
2202/11 (20130101); A61L 2202/24 (20130101); A61L
2202/123 (20130101) |
Current International
Class: |
A61L
2/10 (20060101); A61L 2/24 (20060101) |
Field of
Search: |
;134/6 ;250/455.11
;422/24 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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2009 0075136 |
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Jul 2009 |
|
KR |
|
10-0911729 |
|
Aug 2009 |
|
KR |
|
10-1324463 |
|
Oct 2013 |
|
KR |
|
Primary Examiner: Vanore; David A
Attorney, Agent or Firm: Blank Rome LLP
Claims
The invention claimed is:
1. A sanitization or sterilization device for a stethoscope
comprising a case that accommodates sanitization or sterilization
means, a command and control unit and a battery, said device
comprising means for coupling to the stethoscope to be sanitized or
sterilized, said coupling means being magnetic or electromagnetic
coupling means, mechanical coupling means or a combination thereof,
wherein said case presents to the outside a recess which forms an
inverted cone, the base of which is open and substantially at the
level of the outer surface of the case where a base circumference
is formed, said sanitization or sterilization means being arranged
in correspondence to said cone, wherein, from the base
circumference of the cone, thin, low ribs with chamfered edges
branch-off towards the center of the cone.
2. The device according to claim 1, wherein the case has in cross
section a U-shape, so as to comprise a first chamber, which
comprises said cone and said sanitization or sterilization means,
and a second chamber, which comprises said command and control unit
and said battery, said first and second chambers being joined on
one side by a connecting portion, so that between the two chambers,
externally to them, is formed a cavity in the form of a slot that
constitutes a means for attachment to a garment.
3. The device according to claim 2, wherein on the surface of the
cavity, there are one of more protuberances, fixed or sprung.
4. The device according to claim 1, wherein the oblique side of the
section of the cone perpendicular to its base has an inclination
comprised between 20.degree. and 30.degree. with respect to the
plane of the base.
5. The device according to claim 1, wherein the surface of the cone
facing the aperture is reflective.
6. The device according to claim 5, wherein said surface of the
cone comprises a coating of photocatalytic titanium dioxide.
7. The device according to claim 1, wherein the sanitisation or
sterilisation means comprise one or more UV-C LEDs that emit
radiation with a wavelength between 255 and 300 nm, or about 280
nm.
8. The device according to claim 7, wherein the UV-C LEDs are
arranged in one of the following geometries: a UV-C LED disposed at
the apex of the cone, or three UV-C LEDs arranged or inserted along
the walls of the cone in a configuration of an equilateral triangle
along a circumference coaxial to the base circumference of the cone
and whose projection on the base of the cone is placed at a
distance from the base circumference of r/2 where r is the radius
of the base circumference, or two UV-C LEDs arranged or inserted
along the walls of the cone in an opposed position, or four or more
UV-C LEDs arranged at the vertices of regular polygons.
9. The device according to claim 1, wherein the magnetic coupling
means consist of one or more magnets or electromagnetic elements
positioned on the inner surface of the first chamber of the case,
in correspondence to the cone.
10. The device according to claim 9, wherein the magnets or
electromagnetic elements comprise a plurality of tabs arranged
longitudinally on the inner wall of the cone, or one or more
transverse tabs, or even a single magnetic element in the shape of
a ring, coaxial with respect to the base circumference of the
cone.
11. The device according to claim 1, wherein the mechanical
coupling means comprise a ring nut arranged in correspondence to
the base circumference of the cone and comprising an inner surface
on which is arranged a plurality of engagement members, such as
spring balls, latch levers and the like, and optionally an
insertion niche, and wherein optionally permanent magnets in the
form of tabs, tiles or a continuous circle are arranged inside the
body of the ring nut or on its inner or outer surface.
12. The device according to claim 11, wherein the ring is removable
and has a thread that can be coupled with a threaded edge provided
in correspondence to the base circumference of the cone, or a
bayonet connection system.
13. The device according to claim 11, wherein the ring nut is
solidly associated to the base circumference of the cone.
14. The device according to claim 1, wherein the sanitisation or
sterilisation means are operatively connected to the command and
control unit and the battery via suitable cabling, wherein said
cabling is made to pass through the connecting portion between the
first chamber and second chamber of the case.
15. The device according to claim 1, wherein the command and
control unit comprises a microprocessor or a microcontroller also
with Digital Signal Processing (DSP) functions and wherein the
command and control unit performs the following functions: a)
controls that the device is closed on the head of the stethoscope
and sends a command of consent for the performance of steps b) and
c); b) commands and controls the powering on and off of the UV-C
LEDs based on pre-set power-on times and power output; c) checks
for anomalies, such as a malfunction of the UV-C LED or LEDs and an
insufficient charge of the battery.
16. The device according to claim 1, in which the chamber
externally comprises an extension constituted by a flat surface,
which presents advertising text, identifying data of the operator,
a badge, a screen or other data.
17. The device according to claim 1, comprising a case and a
support element separate from said case, in which the case
comprises the cone with the UV-C LED or LEDs and the command and
control unit or an operational part of it, and said support element
includes the battery and optionally an operational part
complementary to said command and control unit, wherein the case
and the support element comprise coupling means for their mutual
connection, and a conductive pin system for the electrical
connection between the battery and command and control units.
18. The device according to claim 1, comprising a wireless
configuration to interface with electronic devices such as
smartphones, tablets, computers and networks of information systems
and/or a wireless or RFID recognition/security system.
19. The device according to claim 18, wherein said RFID
recognition/security system includes an adhesive receiving antenna
to be placed on the stethoscope, so that, when the stethoscope is
coupled to the device, it gives consent for the powering on of the
UV-C LEDs.
20. The device according to claim 1, wherein the outer edge of the
device comprises an insertion niche formed by a protuberance
towards the inside, below which is placed a micro-switch for
sending a consent signal for powering on the UV-C LEDs.
21. The device according to claim 1, wherein inside the cone is
positioned a visible light and/or proximity sensor for sending a
consent signal for powering on the UV-C LEDs.
22. A kit comprising a device, as defined in claim 1, and a
coupling system with a stethoscope comprising ferromagnetic
elements apt to be positioned on the head of the stethoscope, on
the surface opposite to the membrane to be sterilised, said
ferromagnetic elements comprising one or more adhesive
ferromagnetic strips of varying shape, such as bean, crescent,
ring, tab or semicircle.
23. The kit according to claim 22, comprising a coupling member
positionable on the stethoscope in proximity of the head, wherein
the coupling member comprises a U-shaped support, at the ends of
which are positioned ferromagnetic elements, the U-shaped support
comprising, near the ends, two through holes aligned for the
passage of a fastening pin.
Description
This invention relates to a device for the sanitisation or
sterilisation of medical instruments, in particular
stethoscopes.
In clinical and outpatient practice, doctors and healthcare workers
make extensive use of portable instruments, frequently used for the
assessment of the main physiological functions of the patient, for
treatment and also for communicating and recording clinical
data.
The hygiene of such instruments is of fundamental importance since
it is known that their lack of sterility entails health risks,
often severe. In fact, a large percentage of infectious diseases is
of iatrogenic origin, mainly related to the lack of hygiene. These
diseases, in addition to, obviously, damaging the health of the
patient, significantly increase clinical and healthcare costs.
The vast majority of portable instruments are disposable and, as
such, are suitably enclosed in sealed sterile packages; these
include needles, syringes, gauze, electrodes, etc.
Other, typically more expensive, instruments used by healthcare
professionals, such as scalpels, forceps, surgical instruments,
catheters, etc., are first sterilized each time in special
machines, generally quite expensive, bulky and sophisticated,
placed in specific environments well separated from the operating
theatres.
However, there are varied instruments that are frequently and
commonly used by the medical staff (first of all, doctors), such as
stethoscopes, thermometers, sphygmomanometers,
otorhinolaryngological retractors, ophthalmological frames and
lenses, etc., whose sanitisation must necessarily be frequently
repeated each time they are used on different persons.
Unfortunately, though the problem of cross-infection (from doctor
to patient and from patient to patient via the non-disposable
medical instrumentation) is widely known, clear and scientifically
verified, and there is a wide perception of the great effectiveness
of meticulous sanitisation of these instruments in preventing
associated infections, unfortunately doctors and healthcare workers
continue to pay scant attention to systematically sanitizing
instruments between one patient and another. This is often due to
practical reasons and priorities for medical action mainly aimed at
treating the patient and promptly restoring his vital
functions.
Among the instruments that are frequently and repeatedly used, and
therefore potential vehicles of infection, the stethoscope is the
most common, at high risk for transmission of infections of
iatrogenic origin. The function of the stethoscope is, through
contact between its head with the various parts of the patient, to
detect sounds coming from the patient's organs so that they can be
interpreted in order to determine physiological or pathological
conditions.
The literature provides ample evidence that stethoscopes can be a
vehicle of cross-infection between one patient and another. In
fact, it is rare, although desirable, that a doctor disinfects his
stethoscope after each examination.
A key cause of the failure to sanitise is the practical difficulty
to achieve adequate sanitisation/sterilisation under the doctor's
normal operating conditions. In fact, the stethoscope is an
instrument that the doctor typically carries with him during his
examinations, often moving from place to place, while, as
mentioned, the sterilisation devices are normally bulky and are
housed in special rooms. Therefore, even if the doctor disinfected
it after each examination, it would, most of the time, be hasty,
inadequate and, in any case, uncontrollable in terms of
effectiveness and safety.
Therefore, it would be desirable to have sanitisation systems that
are as simple, light, compact, portable, safe, reliable and
effective as possible to protect healthcare workers and
patients.
For sanitizing or sterilizing medical-healthcare instruments, both
chemicals and approaches based on physical principles can be used.
The latter, with respect to the former, are not affected by
microbial resistance and do not generate it, since they do not
create selection mechanisms, but are generally associated with
cumbersome and expensive devices that are therefore typically
dedicated to hospital use.
Among all physical systems, the use of UV rays is effective and
proven. It has been demonstrated that UV rays have sure
disinfectant power (lowering the microbial charge), especially in
the range of wavelengths comprised between 255 and 280 nm, with an
actual sterilizing effect (inactivation of the microbial charge)
when the exposure time is long enough.
Sanitization devices based on the principle of irradiation with UV
light have already been proposed. However, due to their bulk,
inconvenience of use and complexity, or high cost, they do not
constitute a real solution to the problem that has been described
above.
An important parameter in the design of a device of this type is
the safety of the operator and the patient, in particular to avoid
skin and eye damage caused by UV rays. This problem as well has not
been solved in an easy and economical way by state-of-the-art
devices.
Another important factor is the amount of UV radiation that reaches
the surface to be sanitized. High irradiation efficiency allows
reducing treatment times and sanitizing the entire surface of the
instrument homogeneously.
The purpose of this invention is to provide a device for the
sanitisation or sterilisation of medical-healthcare instruments, in
particular stethoscopes, that solves the problems described above,
and thus: has a weight and compactness that make it truly portable;
is simple, effective and safe to use; allows automatic sanitisation
or sterilisation, even not operator-dependent, in a short enough
time to allow the operator to repeat it after each use; is simple
and economic to make.
This purpose is achieved by a device for the sanitisation or
sterilisation of medical-healthcare instruments as outlined in the
appended claims, whose definitions are an integral part of this
description.
Further characteristics and advantages of this invention will be
more apparent from the description of several embodiments, provided
below as non-limiting examples, with reference to the following
figures:
FIGS. 1A and 1B is a schematic side view in section of the
sanitisation or sterilisation device of the invention;
FIG. 2 is a top perspective view of an anchoring element associable
to the device of FIGS. 1A and 1B;
FIG. 3 is a side view in partial cross-section of the device of the
invention according to an embodiment;
FIG. 4 is a top plan view of the device of the invention according
to an embodiment;
FIG. 5 is a side view in section of a coupling member according to
the invention;
FIG. 6 is a perspective view of the coupling member of FIG. 5 fixed
to a stethoscope;
FIG. 7 is a perspective view of the device of the invention
according to a different embodiment;
FIG. 8 is a plan view of a detail of an embodiment of the
invention;
FIG. 9 is a schematic view in section of a further embodiment of
the invention;
FIG. 10 is a perspective view of a different embodiment of the
invention.
The term "medical-healthcare instrument" refers to an instrument,
or a non-disposable device, that has a surface that is intended to
come into contact with the body of a human being, both for
medical-healthcare reasons, as is the case for the instruments
normally used by doctors and nurses, and for personal reasons, such
as pacifiers and other objects used in infancy. In particular, the
medical-healthcare instrument is a stethoscope.
With reference to the figures, reference number 1 indicates the
sanitisation or sterilisation device according to the invention in
its entirety.
The sanitisation or sterilisation device 1 comprises a case 2 that
houses the sanitisation or sterilisation means 3, a command and
control unit 4 and a battery 5.
The case 2 has a U-shaped cross-section, so as to comprise a first
chamber 6 and second chamber 7 joined on one side by a connecting
portion 8. In this way, between the two chambers and externally to
them, a cavity 9 is formed in the shape of a slot that constitutes
a means for attachment to a garment, for example the pocket of a
white coat. To improve the attachment, one of more protuberances
10, fixed or sprung, are positioned on one of the two walls of the
cavity 9.
In other embodiments, other attachment means may be provided to be
positioned inside the cavity 9, for example pins, clasps, springs
or tabs.
In still other embodiments, the case 2 may comprise a ring for the
passage of a necklace, so as to hang the device on the neck of a
user, or even a gripper to attach it to the collar or other part of
the white coat or other garment.
In an embodiment (FIG. 1A), the first and the second chamber 6, 7
have substantially similar dimensions, so as to distribute the bulk
and weight of the device uniformly between the two parts of the
device, one intended to be positioned externally and the other
internally with respect to the anchoring surface, for example the
surface of a pocket.
In another embodiment (FIG. 1B), for a better stabilisation of the
anchorage to the pocket of the white coat, and for a substantial
reduction of the thickness of the chamber 7--intended to remain
inside the pocket of the white coat--the chamber 7 can be longer
than the chamber 6, extending downwards.
The outer case of chamber 7 can have various shapes with rounded or
square corners, symmetrical or asymmetrical with respect to the
position of the cone.
In a different embodiment, shown in FIG. 7, the chamber 6 may be
provided externally with an extension constituted by a flat surface
34 that faces the outside of the white coat pocket, for example to
contain advertising text, the operator's identifying data, a badge
or other data of healthcare interest. This surface may also contain
a small screen inserted in the badge.
In both of the two embodiments, the first chamber 6 presents to the
outside a recess that forms an inverted cone 11, the base of which
is open and at the level of the outer surface of the case 2, where
it presents a base circumference 11a that constitutes an edge of
the opening, while the apex has a seat in which are housed the
sanitisation or sterilisation means 3.
The diameter of the base of the cone 11 is large enough to
accommodate even larger stethoscopes.
In certain embodiments, the section along a vertical plane of the
cone 11 has the oblique side with an inclination between 20.degree.
and 30.degree. with respect to the base plane of the cone, so as to
limit its height as much as possible and reduce as much as possible
the distance between the sanitisation or sterilisation means 3 and
the surface to be treated.
In certain embodiments, as shown in FIG. 8, from the base
circumference 11a of the cone 11, thin, low ribs 33, 33', 33'' with
chamfered edges branch-off towards the centre of the cone 11. These
ribs 33, 33', 33'' have the function of creating support points for
the head of the stethoscope, keeping it spaced from the cone 11
just enough to maximise the irradiated surface. In fact, by doing
so, the irradiation of the light will better reach the lower
circumference of the head of the stethoscope (membrane and its
anchoring ring). The length of the ribs 33, 33', 33'' is such as to
allow the support of stethoscopes of various sizes.
In certain embodiments, the surface of the cone 11 facing the
aperture is reflective. For example, gold or silver foil or plating
may be provided. The conical shape and reflective properties of the
surface of the cone 11 constitute a waveguide for UV-C rays. This
allows a better directional guidance of the light and captures the
light energy in a smaller volume, improving its effectiveness on
the surface to be treated (membrane of the stethoscope).
Furthermore, when the UV-C 3 LED is positioned at the centre of the
cone 11, there is better protection of the sanitisation or
sterilisation means 3, minimising the need to coat it with quartz
or film transparent to the UV radiation.
As a reflective coating, certain embodiments may provide a titanium
dioxide coating, in particular titanium dioxide in nanoparticle
form that, in addition to having high reflective properties, in the
presence of UV radiation performs a photocatalytic action that
improves the sanitizing and antibacterial effect of the device.
The sanitisation or sterilisation means 3 are preferably means for
the emission of UV-C radiation. More preferably, such means
comprise one or more UV-C LEDs that emit radiation with a
wavelength between 255 and 300 nm, and preferably about 280 nm.
In a different embodiment of the invention, shown in FIG. 4, in
which there are three UV-C 3 LEDs 3', 3'', these are disposed
along, and preferably inserted flush in, the walls of the cone 11
in a triangular configuration.
Preferably, the UV-C LEDs 3, 3', 3'' have an irradiation angle
between 120.degree. and 140.degree. and are placed in the
configuration of an equilateral triangle along a circumference
coaxial to the base circumference 11a of the cone 11 and whose
projection on the base of the cone 11 is placed at a distance from
the base circumference 11a of r/2 where r is the radius of the base
circumference. In this way, total irradiation of the surface to be
treated is obtained, reducing exposure times due to the shorter
distance between the UV-C LEDs 3, 3', 3'' and the surface to be
treated.
In other embodiments (not shown), one can use just two UV-C LEDs,
arranged, and preferably inserted flush, always along the walls of
the cone 11 in opposing position. In this way, oval irradiation
projections are created, suitable to best cover, compared to the
single UV LED, the possible areas of side shadow, to strengthen the
irradiation energy in the central areas of the cone 11 and to allow
a multiplication of the UV-C rays going, in part, to irradiate the
reflective surface of the cone 11 itself.
In still other embodiments, four or more UV-C LEDs may be used,
arranged at the vertices of regular polygons.
The UV-C LEDs can be powered with direct current or, alternatively,
using current waveforms to optimise light intensity and therefore
maximise the biocidal effect. For example, one can use pulsing
waveforms such as pulsed, triangular, square, sinusoidal,
intermittent, etc., working at an appropriate frequency.
The device of the invention comprises means for coupling to the
medical-healthcare instrument to be sanitized or sterilized. These
coupling means may be magnetic coupling means, mechanical coupling
means or a combination of them (magneto-mechanical means).
The magnetic coupling means consist of one or more permanent
magnets 12 positioned on the inner surface of the first chamber 6
of the case 2, in correspondence to the cone 11. The magnets 12 may
include a plurality of tabs arranged longitudinally on the inner
wall of the cone 11 (as shown in FIG. 3), or one or more transverse
tabs, or even a single magnetic element in the shape of a ring,
coaxial with respect to the base circumference 11a of the cone 11.
Obviously, the magnets 12 may assume any other shape and be in even
or odd number and preferably be arranged at a regular distance from
one another.
In certain embodiments, the permanent magnets 12 can be replaced by
electromagnets.
The mechanical coupling means comprise a ring nut 13 (FIG. 2) that
has an internal thread 14 that can be coupled with a threaded edge
15 (FIG. 3) provided in correspondence to the base circumference of
the cone 11. In other embodiments (not shown), the thread 14 can
instead be arranged externally. While, in other embodiments, the
thread 14 of the ring nut 13 and the threaded edge 15 of the case 2
are replaced by a bayonet coupling system of conventional type.
The ring nut 13 includes an inner surface 16 on which is disposed a
plurality of engagement members 17, such as spring balls (shown in
FIG. 2), the latch levers or similar and mechanical insertion
niches. The engagement members may all be of the same type
(homogeneous) or combined types. For example, as shown in FIG. 10,
two spring balls and an insertion niche 36 so that the stethoscope
is first slid under the niche 36 by appropriately tilting it, and
then hooked by the engagement members (spring balls) 17. In each of
these systems, it is possible to fix the head of the stethoscope to
the ring nut 13 through the interaction of the edge of the
stethoscope with the engagement members 17.
The insertion niche 36 is formed by a protuberance towards the
inside of the outer edge of the cone 11, so as to create the space
of the niche 36 below it.
In certain embodiments, permanent magnets in the shape of tabs,
tiles or a continuous circle may be arranged within the body of the
ring nut 13 or on its inner or outer surface. In this way, it will
be possible to integrate the mechanical and magnetic couplings of
the case 2 obtaining a more stable coupling.
The fact that the ring nut 13 is removable from the case 2 allows
its use only in cases where it is not possible to associate a
ferromagnetic element to the head of the stethoscope or when it is
desired to use both the magnetic and mechanical couplings
simultaneously.
Furthermore, the removability of the ring nut 13 allows using ring
nuts 13 of different size, so as to adapt the device of the
invention to stethoscopes of various types.
In other embodiments, the ring nut 13 will be integrally associated
to the edge of the base circumference 11a of the cone 11.
In an embodiment (FIG. 1A), the second chamber 7 of the case 2
houses the command and control unit 4 and the battery 5. In this
embodiment, the command and control unit 4 and the battery 5 are
stacked.
In another embodiment (FIG. 1B), the second chamber 7 of the case 2
houses the command and control unit 4 and the battery 5 so that the
command and control unit 4 and the battery 5 are arranged side by
side on the same plane. This allows limiting the thickness of the
chamber 7, intended to be accommodated in the pocket of an
operator. In this case, the cavity 9 will preferably be shorter,
remaining below the position of the LED.
The sanitisation or sterilisation means 3 are operatively connected
to the command and control unit and the battery 5 via suitable
cabling 18, 19, which is made to pass through the connecting
portion 8 between the first chamber 6 and second chamber 7.
Various connection methods may be provided. A first possibility is
that shown in the figures, in which the LED or LEDs 3, 3', 3'' are
connected to the command and control unit 4 via a first cable 18,
while the command and control unit 4 is connected to the battery 5
via a second cable 19. In other embodiments, the cables 18, 19
directly connect the battery 5 to the LEDs 3, 3', 3'' and command
and control unit 4. In still other embodiments, a connection could
be made between the LEDs 3, 3', 3'' and the command and control
unit 4 by means of suitable jacks.
The command and control unit 4 comprises a microprocessor or a
microcontroller also with Digital Signal Processing (DSP)
functions.
The command and control unit 4 performs the following
functions:
a) controls that the device 1 is closed on the head T of the
stethoscope S and sends a command of consent for the performance of
steps b) and c);
b) commands and controls the powering on and off of the UV-C LEDs
3, 3', 3'' based on the pre-set power-on times and power
output;
c) checks for anomalies, such as a malfunction of the UV-C LED or
LEDs 3, 3', 3'' and an insufficient charge of the battery 5.
These operations are performed using conventional elements and
logical that are full known to an expert in the field.
It is essential that step a) be performed first, so as to send the
microprocessor a command of consent to step b).
Step c) can be performed at any time.
The closure control according to step a) is important in order to
ensure safety for the operator and patient. In fact, if the UV-C
LEDs 3, 3', 3'' go into operation before the closure of the device,
the UV-C radiation could be harmful for the health or the operator
or the patient, especially if they reach the eyes or other
sensitive parts of the body.
In certain embodiments, the control according to step a) is
implemented by means of a contact or magnetic induction pressure
and/or spring micro-switch 37 arranged in a suitable position along
the base circumference 11a, to protect it from accidental
activation. For example, as shown in FIG. 10, the micro-switch 37
is positioned below the insertion niche 36 of the stethoscope,
which prevents accidental pressing of the micro-switch, for example
with the fingers.
The spring or button micro-switch 37 closes or opens the electric
circuit depending on whether the device 1 is, respectively, coupled
or decoupled to the stethoscope S. In certain embodiments, in
addition to, or in place of, the switch described above, there may
be a visible light and/or proximity sensor 35 (FIG. 7) connected to
the command and control unit 4 to send a power-on command only if
visible light is not detected in the cone 11 (light sensor) and/or
if the proximity of the head of the stethoscope is not detected
(proximity sensor). In fact, this would mean that the closure of
the device 1 on the stethoscope S was not performed properly.
As mentioned previously, the coupling of the medical-healthcare
device, in particular a stethoscope, to the sanitisation or
sterilisation device 1 can take place by magnetic, mechanical or
magneto-mechanical means. In the case of magnetic means, it is
necessary that the stethoscope comprise ferromagnetic elements that
can be attracted by the magnets present on the device of the
invention.
If the stethoscope does not include ferromagnetic elements, this
invention has a coupling system that provides for the positioning
of additional ferromagnetic elements 27 (FIG. 6) on the
stethoscope.
These ferromagnetic elements can be one or more ferromagnetic
adhesive strips 27 of varying shape (bean, crescent, ring, tab,
semicircle, etc.) that can be applied to the head T of the
stethoscope S, on the surface opposite to the membrane to be
sterilised.
In an embodiment, shown in FIGS. 5 and 6, there is provided a
coupling member 20 to be positioned astride the connection nozzle
21 of the stethoscope with the tube 22 that leads to the earphones.
The coupling member 20 comprises a U-shaped support 23 with
ferromagnetic elements 24 positioned at the ends. The U-shaped
support 23 comprises, always in proximity of the ends, two through
holes 25, 25' aligned for the passage of a fastening pin 26, for
example a fastening screw. The coupling member 20 is then placed
astride the nozzle with the ferromagnetic elements 24 facing
downwards so as to flank the surface to be sterilized and allow
interaction with the magnets present on the device of the
invention. The fastening pin 26, which will allow the stable
coupling of the coupling member 20 to the stethoscope S is then
inserted and screwed. If necessary in this embodiment too one or
more ferromagnetic strips 27 can be applied on the upper surface 28
of the stethoscope.
In this way the stethoscope is provided with the necessary
ferromagnetic elements that will allow magnetic coupling by
attraction with the magnets of the device 1 of the invention.
The sanitisation or sterilisation device can be carried in a
pocket. The particular shape of the case 2, which presents the
cavity 9 dividing the bulk of the device into two portions (first
and second chambers 6, 7) of an equivalent size in an embodiment
(FIG. 1A) or with a chamber 7 longer than chamber 6 in another
embodiment (FIG. 1B), allows optimising the portability of the
device. In fact, the cavity 9 acts as a spring clip for fastening
to a vest pocket of the white coat (or to a belt or a bag), so that
the portion of the case 2 that contains the battery 5 and the
command and control unit 4 remains inside the pocket, while the
portion comprising the sanitisation or sterilisation means 3 and
the cone 11 is positioned externally. It follows that the bulk of
the projecting part is minimal and also the weight of the device is
balanced between the two portions.
In a different embodiment, shown in FIG. 9, the device 1 is
composed of two separate parts: a case 2', comprising the cone 11
with UV-C LED or LEDs 3, 3', 3'', the command and control unit 4,
and a support element 2'' to which the battery 5 is associated.
As shown in the figure, the command and control unit 4 can also be
divided between the case 2' and support element 2'', having a first
operating part 4', equipped for example with the electronic
circuits for feeding and recharging the battery 5, in the support
element 2'', and a second operating part 4, equipped for example
with the remaining electronic control circuits, inside the case 2'.
The case 2' and the support element 2'' comprise coupling means 30
for their mutual connection, such as an automatic button system or
magnetic means. In this way, the device 1 can be disposed in any
position of a white coat or other garment, without the need of a
pocket or lapel, since the support element 2'' will be positioned
on the inner face of the fabric TS and the case 2' on the outer
face, connecting the two parts through the fabric TS by the
coupling means 30, snap or magnetic.
The support element 2'' may comprise a lower portion 31, which can
be part of the body of the battery 5, and which, positioned below
with respect to the case 2', can counterbalance the weight of the
latter.
The electrical connection between the battery 5 and the command and
control unit 4 or between the battery 5 and element 4' from one
side and the command and control unit 4 from the other side, can
occur by means of a conductive pin system 32 that passes through
the fabric TS.
The presence of the cone 11, on whose surface facing towards the
interior of the chamber 6 the magnets 12 are arranged, allows
coupling with stethoscopes even of different sizes. In fact, the
magnetic coupling may take place along the whole surface of the
cone 11, not necessarily only along the base circumference 11a. The
same advantage can be achieved also in the case of mechanical
coupling by replacing the ring nut 13 based on the shape and size
of the stethoscope.
The sanitisation or sterilisation device 1 may be accompanied by a
protective container (not shown). The protective container can be
used when the device 1 is not used.
In general, the material of which device 1 is made is a material
resistant to UV radiation, so as not to be deteriorated or damaged
after a few uses by the operator, which can also occur in an
inappropriate way.
The operation of the device 1 according to the invention is clear
from what has been described above. After completing an
examination, the medical-healthcare operator can couple the head of
the stethoscope S to the device 1 in a simple and immediate way
thanks to the magnetic, mechanical or even magnetic/mechanic
coupling provided above.
At this point, the sanitisation/sterilisation cycle will be
initiated manually or automatically and, when completed, the
operator can decouple the device 1 from the stethoscope, which will
be ready for a new use.
In certain embodiments, the device 1 can emit an acoustic, visual
or vibratory signal to signal the end of the
sanitisation/sterilisation cycle.
The battery can be charged wirelessly or by connection to the
mains. In certain embodiments, the command and control unit 4 can
regulate the power outputted by the UV-C LEDs 3, 3', 3'' delivering
more power if the device is connected to the mains, for example
during the battery recharging phase, in order to fully sanitise or
sterilise the medical device. Doing so will ensure sanitisation or
sterilisation during the non-operational phase and, at the same,
extend battery life.
The device of the invention can be wireless or Bluetooth-enabled to
interface with electronic devices such as smartphones, tablets,
computers and networks of information systems. This in order to
display information about the device, such as for example, checking
the charge level of the battery, the ageing of the UV-C LED, the
duration of the disinfection time, check dates, times and
frequencies/daily numbers for the use of the device, record and
verify a serial number of the device, download the data on storage
media, transmit the data to servers or computerised control systems
or check that the electronics are operating properly (system
check-up).
In certain embodiments, the device of the invention may comprise a
Bluetooth or RFID recognition system in order to customise the
device. The RFID system can also be used as a security system by
configuring it as a sticker to be placed on the stethoscope (head
or tube), so that, when the stethoscope is coupled to the device of
the invention, it will give consent for powering on the UV-C
LEDs.
The advantages of the sanitisation or sterilisation device 1
according to the invention are obvious.
The device is of minimal weight and size and is portable.
Despite being associable and dissociable from the stethoscope with
a single gesture, thanks to magnetic, or mechanical or
magneto-mechanical means, it may nevertheless be completely
separated from the stethoscope, thus avoiding both its
contamination during use of the stethoscope on the patient and its
being a hindrance for the operator.
The use of the UV-C LEDs 3, 3', 3'' allows the miniaturisation of
the device.
The provision of the cone 11 as waveguide ensures a complete and
effective irradiation of the entire surface to sanitized quickly,
perfectly compatible with the passage of examining one patient
after another, even using a single UV-C LED. Taking into account
that the latter is the element of greatest cost of the device, the
possibility of using only a single LED to cover the entire surface
ensures a substantial reduction of manufacturing costs, as well as
a greater battery life.
The command and control unit 4 allows performing all operations
completely automatically, since the duration and intensity of the
sterilisation cycle is regulated by a microprocessor or
microcontroller, providing, at the same time, safety for both the
operator and the patient because the operation of the UV-C LED is
inhibited if the device is not properly closed on stethoscope or
opened before the completion of sanitisation or sterilisation.
It obvious that only several particular embodiments of the present
invention have been described, to which an expert in the art will
be able to make any necessary modifications for its adaptation to
particular applications without, however, departing from the scope
of protection of this invention as defined in the appended
claims.
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